Study of Progesterone in Treatment of Vasomotor Symptoms

Brief description of study

The primary objective of the clinical trial is to demonstrate superiority of BHR401 (oral
micronized progesterone) versus placebo as a monotherapy for moderate to severe VMS in
postmenopausal women. Three different doses of BHR-401 (200 mg, 300 mg or 400 mg) will be
tested against placebo in hierarchical order, starting with the highest dose. Superiority
will be defined as a significant (significance level = 0.05) reduction of moderate to
severe VMS frequency compared to placebo at treatment week 12 (the primary efficacy endpoint
of the study).